It was time within our ruminations on China to speak directly with a quality executive at a drug developer and manufacturer based there. That’s now accomplished via a discussion with Diana Francis, Vice President, Quality & Compliance, BeiGene, Ltd., a biopharma some have dubbed as a potential “Genentech of China.” Francis spoke openly about her role, BeiGene’s global strategy, and outsourcing within and from China.
This is the second of two articles focusing on the issues that pharma companies face when moving into the digital health space. In the first installment, the development process, agency guidance, and the type of quality oversight needed for software incorporated into medical device and combination products were explored. This part focuses on the importance of cybersecurity and software maintenance, how time scales and methods of execution differ from those in traditional pharma, how agile software development works, and how to avoid potential pitfalls.
Merck’s recent announcement that its infliximab biosimilar, Renflexis, was awarded a U.S. Department of Veterans Affairs (VA) national contract has sparked curiosity about the potential influence this might have on biosimilar adoption and formulary preference in the rest of the market. Renflexis was determined to be the lowest-priced infliximab proposed under a competitive solicitation and, as such, was awarded preferred use as the only infliximab option covered on the VA National Formulary (VANF).
Heart problems have touched many of our lives, or the lives of those we care about. Heart attacks and heart failure are leading killers in the U.S.,1 with limited treatment options available today. Typically, a heart attack is followed by significant heart muscle cell death, leaving the organ in a weakened state and the patient at risk of cardiovascular dysfunction and eventual heart failure. This leads to many of the deaths attributed to cardiovascular disease.
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reducing both risk and the time needed for delivery of critical clinical supplies.
This whitepaper discusses cleaning of affinity resins intended for use in the purification of monoclonal antibodies and antibody fragments.
The expanding global pharmaceutical industry projects a 4%-6% annual growth and forecasts that it will reach a value of $1T by 2014. By Paul Dupont
Transferring production — and the technologies that undergird it — can be risky. The same product can behave differently in different equipment, resulting in low yields or even batch rejections.
Some products cannot be filtered prior to final fill, requiring a process which limits particulate-contributing factors wherever possible. Pre-cleaned, sterile, ready-to-use containers ease this burden.
By William Whitford, Strategic Solutions Leader, BioProcess, GE Healthcare Life Sciences
The industry is abuzz with talk about continuous biomanufacturing (CB), and its virtues have been well described. Here we will look at some of the barriers or concerns perceived to limit its value to the industry. Justified or not, quite a few concerns have been expressed regarding the implementation of this new, rather disruptive technology.
Management of medication delivery through lyophilization - freeze-drying - is a crucial enabling process technology for many important parenteral drugs. Close to 50% of biopharmaceuticals, including enzymes, proteins and monoclonal antibodies, must be lyophilized as these therapeutic agents are insufficiently stable for ready-to-use solution dosage forms. A small but growing number of small-molecule drugs are also prepared in this manner. It is a safe bet that without lyophilization, the majority of these products would not be available.
In this study, the native production and titer activity for secreted Proteinase K from Tritirachium album (T. album) during the course of an 11-day culture were compared between the S.U.F. and stainless steel fermentor systems.
Integrate sterile and efficient temperature control with the DHX Heat Exchanger. The purpose of this tech note is to present the benefits of the Thermo Scientific DHX Heat Exchanger and its applications.
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OutsourcedPharma.com provides comprehensive analysis of global outsourcing, the biotechnology and pharmaceutical industries, and their intersection with the overall life sciences and healthcare markets. We offer readers a deeper exploration and understanding of the relationships between service providers and their bio and pharma sponsors.
Tips to prevent bioburden entry and proliferation, and reduce the complexity of the equipment and processes involved.
Currently, there is a transformation taking place that will pave the way for even more changes to how the industry approaches drug manufacturing.
Bioprocessing development is a long and costly process. Building in continuous characterization and connected bioprocessing cuts timelines and increases the available information through real-time analytics.
Before you sign on the dotted line, do a little digging to unearth potential costs that could turn your development program into a cash-burning exercise.
Trevor Marshall of Zenith Technologies discusses the impact that multi-product manufacturing facilities, single-use technologies, continuous manufacturing and industry 4.0 will have on automation.
